Easily cleaned atherectomy catheters and methods of use

ABSTRACT

An atherectomy catheter is provided having a tissue collection chamber capable of being cleaned out in a simple, fast and effective way, and also provides methods of using said catheter to remove material from a blood vessel lumen. In one embodiment the tissue collection chamber has an expandable tip having a first closed position capable of retaining material in the chamber and having a second open position that may allow expulsion of material from the chamber. In a second embodiment the tissue collection chamber has a displaceable tip having a first closed position to retain material in the chamber and having a second open position to allow expulsion of material from the chamber.

This application claims the benefit of U.S. Provisional PatentApplication No. 61/178,119, filed May 14, 2009, entitled “Easily CleanedAtherectomy Catheters and Methods Of Use”, the contents of which arehereby incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to catheters used to remove material froma site in a body lumen. More particularly, this invention pertains toremoval of material stored in such a catheter.

BACKGROUND OF THE INVENTION

Atherosclerosis is a progressive disease of the vascular system wherebyatheroma is deposited on the inner walls of blood vessels. Over timeatheromatous deposits can become large enough to reduce or occlude bloodflow through the vessels, leading to symptoms of low blood flow such aspain in the legs (on walking or at rest), skin ulcer, angina (at rest orexertional), and other symptoms. To treat this disease and improve orresolve these symptoms it is desirable to restore or improve blood flowthrough the vessel.

Various means are used to restore or improve blood flow throughatheromatous vessels. The atheroma deposits can be displaced bydiametrically expanding the vessel by inflating balloons, expandingstents, and other methods. However these methods undesirably tear andstretch the vessel, causing scar formation in a high percentage ofpatients. Such scar tissue (restenotic material), once formed, blocksflow in the vessel and often needs to be removed. The deposits can bepulverized using lasers and other methods. However pulverization aloneof atheromatous material allows microemboli to flow downstream and lodgein distal vascular beds, further compromising blood flow to the tissueaffected by the disease. Atherectomy catheters can be used to removeatheromatous deposits from the blood vessel and can present an idealsolution when the deposits removed from the vessel are captured andremoved from the body. One way to capture and remove such deposits is tostore the deposits within the catheter and to subsequently remove thecatheter from the body.

One problem that occurs when storing material or deposits in a catheteris that the catheter can have insufficient storage capacity. The portionof the vessel to be treated can be quite extensive. For example, theportion of the vessel to be treated can extend over a vessel length of200 mm or longer. If the storage chamber in the catheter becomes filledwith material the catheter must be removed from the body, the depositsremoved from the catheter, and the catheter re-inserted into the bodyfor more deposit removal and storage. However, present methods forremoving deposits from catheter collection chambers can be timeconsuming.

What is needed is a catheter having a simple, fast and effective way ofremoving deposits from a catheter collection chamber.

SUMMARY OF THE INVENTION

The present invention provides an atherectomy catheter having a tissuecollection chamber capable of being cleaned out in a simple, fast andeffective way, and also provides methods of using the catheter to removematerial from a blood vessel lumen. In one embodiment the tissuecollection chamber has an expandable tip having a first closed positioncapable of retaining material in the chamber and having a second openposition that may allow expulsion of material from the chamber. In asecond embodiment the tissue collection chamber has a displaceable tiphaving a first closed position to retain material in the chamber andhaving a second open position to allow expulsion of material from thechamber.

The invention provides an atherectomy catheter comprising: a body havingan opening; a rotatable shaft coupled to the body, the rotatable shaftbeing rotatable about a longitudinal axis of the shaft; a tissuecollection chamber coupled to the body and positioned distal to thecutting element; and a cutting element coupled to the rotatable shaft,the cutting element having a cup-shaped surface and a cutting edge, thecup-shaped surface being configured to re-direct tissue cut by thecutting edge in a distal direction when the cup-shaped surface moves inthe distal direction. The tissue collection chamber has a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from thechamber. The tissue collection chamber comprises an expandable tip at adistal region of the catheter, the expandable tip having a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from a distalopening at a distal end of the chamber.

The invention provides an atherectomy catheter comprising: a body havingan opening; a rotatable shaft coupled to the body, the rotatable shaftbeing rotatable about a longitudinal axis of the shaft; a tissuecollection chamber coupled to the body and positioned distal to thecutting element; and a cutting element coupled to the rotatable shaft,the cutting element having a cup-shaped surface and a cutting edge, thecup-shaped surface being configured to re-direct tissue cut by thecutting edge in a distal direction when the cup-shaped surface moves inthe distal direction. The tissue collection chamber has a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from thechamber. The tissue collection chamber comprises a displaceable tip at adistal region of the catheter, the displaceable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue fromthe chamber, the displaceable tip being attached to the atherectomycatheter in both the first closed and second open positions.

The invention provides a method of removing material from a body lumen,the method comprising: providing an atherectomy catheter, theatherectomy catheter comprising: a body having an opening; a rotatableshaft coupled to the body, the rotatable shaft being rotatable about alongitudinal axis of the shaft; a tissue collection chamber coupled tothe body and positioned distal to the cutting element; and a cuttingelement coupled to the rotatable shaft, the cutting element having acup-shaped surface and a cutting edge, the cup-shaped surface beingconfigured to re-direct tissue cut by the cutting edge in a distaldirection when the cup-shaped surface moves in the distal direction,wherein the tissue collection chamber has a first closed positioncapable of retaining cut tissue in the chamber and a second openposition capable of allowing expulsion of cut tissue from the chamber,and wherein the tissue collection chamber comprises an expandable tip ata distal region of the catheter, the expandable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue from adistal opening at a distal end of the chamber; placing the catheter inthe body lumen; and moving the catheter in the body lumen to contact thecutting element with the material in the body lumen.

The invention provides a method of removing material from a body lumen,the method comprising: providing an atherectomy catheter, theatherectomy catheter comprising: a body having an opening; a rotatableshaft coupled to the body, the rotatable shaft being rotatable about alongitudinal axis of the shaft; a tissue collection chamber coupled tothe body and positioned distal to the cutting element; and a cuttingelement coupled to the rotatable shaft, the cutting element having acup-shaped surface and a cutting edge, the cup-shaped surface beingconfigured to re-direct tissue cut by the cutting edge in a distaldirection when the cup-shaped surface moves in the distal direction,wherein the tissue collection chamber has a first closed positioncapable of retaining cut tissue in the chamber and a second openposition capable of allowing expulsion of cut tissue from the chamber,and wherein the tissue collection chamber comprises a displaceable tipat a distal region of the catheter, the displaceable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue fromthe chamber, the displaceable tip being attached to the atherectomycatheter in both the first closed and second open positions; placing thecatheter in the body lumen; and moving the catheter in the body lumen tocontact the cutting element with the material in the body lumen.

These and other aspects of the invention will become apparent from thefollowing description of the preferred embodiments, drawings and claims.The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an isometric view of an atherectomy catheter.

FIG. 2 illustrates an isometric cross-sectional view of a portion of theatherectomy catheter illustrated in FIG. 1 with a cutting element in astored position.

FIG. 3 illustrates an isometric cross-sectional view of a portion of theatherectomy catheter illustrated in FIG. 1 with a cutting element in aworking position.

FIG. 4 illustrates an isometric view of an embodiment of a cuttingelement.

FIG. 5 illustrates an end view of an embodiment of a cutting element.

FIGS. 6 and 7 illustrate partial cross section views of a portion of anatherectomy catheter.

FIG. 6A illustrates an end view of the atherectomy catheter illustratedin FIG. 6.

FIG. 8 illustrates a side view of a portion of the catheter illustratedin FIGS. 6, 6A and 7.

FIGS. 9, 10 and 11 illustrate partial cross section views of a portionof the atherectomy catheter illustrated in FIGS. 6, 6A, 7 and 8 invarious stages of use.

FIGS. 12 and 13 illustrate partial cross section views of a portion ofanother atherectomy catheter.

FIGS. 14 and 15 illustrate partial cross section views of a portion ofthe atherectomy catheter illustrated in FIGS. 12 and 13 in variousstages of use.

DETAILED DESCRIPTION

The invention provides an atherectomy catheter comprising: a body havingan opening; a rotatable shaft coupled to the body, the rotatable shaftbeing rotatable about a longitudinal axis of the shaft; a tissuecollection chamber coupled to the body and positioned distal to thecutting element; and a cutting element coupled to the rotatable shaft,the cutting element having a cup-shaped surface and a cutting edge, thecup-shaped surface being configured to re-direct tissue cut by thecutting edge in a distal direction when the cup-shaped surface moves inthe distal direction. The tissue collection chamber has a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from thechamber. The tissue collection chamber comprises an expandable tip at adistal region of the catheter, the expandable tip having a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from a distalopening at a distal end of the chamber. In an embodiment, the tissuecollection chamber comprises a sheath having a lumen.

In one embodiment, the tissue collection chamber comprises one or moreslots in a distal region of the sheath. In another embodiment, thetissue collection chamber comprises two or more slots in a distal regionof the sheath. The distal region of the sheath may comprise 2, 3, 4, 6,8, 12, or 16 slots. In an embodiment, the distal region of the sheathhas a distally tapering diameter. In one embodiment, the tissuecollection chamber has a distal opening in the first closed position.

In an embodiment, the tissue collection chamber comprises a shim sleevedisposed within the lumen of the sheath, the shim sleeve being axiallyslidable relative to the sheath, and the shim sleeve having a lumen. Inone embodiment, the shim sleeve may comprise a window. In an embodiment,the cutting element may be deployed through the shim sleeve window andthe opening of the catheter. In an embodiment, the distal region of thesheath can be expanded by moving the shim sleeve distally. In oneembodiment, the sheath is pre-programmed to assume the first closedposition.

In one embodiment, the cutting element can be extended distally throughthe lumen of the shim sleeve. In an embodiment, the cutting element canbe extended distally through a distal opening of the sheath when thetissue collection chamber is in the second open position. In oneembodiment, the tissue collection chamber comprises a guidewire lumen.

In one embodiment, the tissue collection chamber comprises one or moreslots in a distal region of the sheath, the distal region of the sheathhas a distally tapering diameter, and the tissue collection chambercomprises a shim sleeve disposed within the sheath, the shim sleevebeing axially slidable relative to the sheath, and the shim sleevehaving a lumen. In an embodiment, the distal region of the sheath can beexpanded by moving the shim sleeve distally.

The invention provides an atherectomy catheter comprising: a body havingan opening; a rotatable shaft coupled to the body, the rotatable shaftbeing rotatable about a longitudinal axis of the shaft; a tissuecollection chamber coupled to the body and positioned distal to thecutting element; and a cutting element coupled to the rotatable shaft,the cutting element having a cup-shaped surface and a cutting edge, thecup-shaped surface being configured to re-direct tissue cut by thecutting edge in a distal direction when the cup-shaped surface moves inthe distal direction. The tissue collection chamber has a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from thechamber. The tissue collection chamber comprises a displaceable tip at adistal region of the catheter, the displaceable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue fromthe chamber, the displaceable tip being attached to the atherectomycatheter in both the first closed and second open positions. In oneembodiment, the tissue collection chamber comprises a sheath having alumen. In an embodiment, the displaceable tip is axially slidablerelative to the sheath. In an embodiment, the displaceable tip isdisposed on a push shaft that is axially slidable relative to thesheath. In one embodiment, the push shaft is received within the lumenof the sheath. In an embodiment, the push shaft has a partially circularcross section. In another embodiment, the push shaft has anapproximately semi-circular cross section.

In an embodiment, a proximal portion of the displaceable tip has areduced diameter and is capable of being received within the lumen ofthe sheath. In one embodiment, a distal region of the displaceable tiphas a distally tapering diameter.

In one embodiment, the cutting edge is a radially outer edge of thecutting element. In an embodiment, the cutting element is movablebetween a stored position and a cutting position relative to theopening. In one embodiment, the cutting element is moved between thestored position and the cutting position by sliding the cutting elementagainst a cam surface. In one embodiment, a distal portion of thecatheter relative to a proximal portion is deflected by sliding thecutting element against the cam surface.

The invention provides a method of removing material from a body lumen,the method comprising: providing an atherectomy catheter, theatherectomy catheter comprising: a body having an opening; a rotatableshaft coupled to the body, the rotatable shaft being rotatable about alongitudinal axis of the shaft; a tissue collection chamber coupled tothe body and positioned distal to the cutting element; and a cuttingelement coupled to the rotatable shaft, the cutting element having acup-shaped surface and a cutting edge, the cup-shaped surface beingconfigured to re-direct tissue cut by the cutting edge in a distaldirection when the cup-shaped surface moves in the distal direction,wherein the tissue collection chamber has a first closed positioncapable of retaining cut tissue in the chamber and a second openposition capable of allowing expulsion of cut tissue from the chamber,and wherein the tissue collection chamber comprises an expandable tip ata distal region of the catheter, the expandable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue from adistal opening at a distal end of the chamber; placing the catheter inthe body lumen; and moving the catheter in the body lumen to contact thecutting element with the material in the body lumen. In one embodiment,the catheter is moved in a distal direction to contact the cutting edgewith the material in the body lumen. In an embodiment, the catheter isplaced in the body lumen with the cutting element in a stored positionand the catheter is moved to contact the material with the cuttingelement in a cutting position.

In one embodiment, the method further comprises collecting the materialin the tissue collection chamber, removing the catheter from the bodylumen, and removing the material from the tissue collection chamberafter the catheter has been removed from the body lumen. In anembodiment, the catheter is removed from the body lumen with the tissuecollection chamber in the first closed position and the material isremoved from the tissue collection chamber with the tissue collectionchamber in a second open position capable of allowing expulsion of cuttissue from the chamber.

The invention provides a method of removing material from a body lumen,the method comprising: providing an atherectomy catheter, theatherectomy catheter comprising: a body having an opening; a rotatableshaft coupled to the body, the rotatable shaft being rotatable about alongitudinal axis of the shaft; a tissue collection chamber coupled tothe body and positioned distal to the cutting element; and a cuttingelement coupled to the rotatable shaft, the cutting element having acup-shaped surface and a cutting edge, the cup-shaped surface beingconfigured to re-direct tissue cut by the cutting edge in a distaldirection when the cup-shaped surface moves in the distal direction,wherein the tissue collection chamber has a first closed positioncapable of retaining cut tissue in the chamber and a second openposition capable of allowing expulsion of cut tissue from the chamber,and wherein the tissue collection chamber comprises a displaceable tipat a distal region of the catheter, the displaceable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue fromthe chamber, the displaceable tip being attached to the atherectomycatheter in both the first closed and second open positions; placing thecatheter in the body lumen; and moving the catheter in the body lumen tocontact the cutting element with the material in the body lumen. In oneembodiment, the catheter is moved in a distal direction to contact thecutting edge with the material in the body lumen. In an embodiment, thecatheter is placed in the body lumen with the cutting element in astored position and the catheter is moved to contact the material withthe cutting element in a cutting position.

In one embodiment, the tissue collection chamber comprises a sheathhaving a lumen. In one embodiment, the displaceable tip is axiallyslidable relative to the sheath.

In one embodiment, the method further comprises collecting the materialin the tissue collection chamber, removing the catheter from the bodylumen, and removing the material from the tissue collection chamberafter the catheter has been removed from the body lumen. In anembodiment, the catheter is removed from the body lumen with the tissuecollection chamber in the first closed position and the material isremoved from the tissue collection chamber with the tissue collectionchamber in a second open position capable of allowing expulsion of cuttissue from the chamber.

Referring to FIGS. 1 to 4, an atherectomy catheter 2 is shown which hasa cutting element 4 which is used to cut material from a blood flowlumen such as a blood vessel. The cutting element 4 is movable between astored position (FIG. 2) and a cutting position (FIG. 3) relative to anopening 6 in a body 8 of the catheter 2. The cutting element 4 movesoutwardly relative to the opening 6 so that a portion of the element 4extends outwardly from the body 8 through the opening 6. In oneembodiment the cutting element 4 may be positioned relative to the body8 and opening 6 so that less than 90 degrees of the cutting element 4 isexposed to cut tissue. In other embodiments more of the cutting element4 may be exposed without departing from numerous aspects of theinvention.

Distal end of catheter 2 is positioned near a treatment site in a vesselwith cutting element 4 in the stored position. Then catheter 2 is moveddistally through the vessel with the cutting element 4 in the working orcutting position as described in further detail below. As the catheter 2moves through the blood vessel with the cutting element 4 in the workingor cutting position the tissue material is cut by the cutting element 4and is directed into a tissue chamber 12 positioned distal to thecutting element 4. The tissue chamber 12 may be somewhat elongated toaccommodate the tissue which has been cut.

In some embodiments catheter 2 has a working length of 30 to 200 cm. Inone embodiment catheter 2 has a working length of 135 cm. In someembodiments catheter 2 has a diameter of 4 Fr to 12 Fr (1.3 mm to 4 mm).In one embodiment catheter 2 has a diameter of 7 Fr (2.3 mm).

To expose cutting element 4 through opening 6 cutting element 4 is movedproximally from the stored position so that a cam surface 14 on thecutting element 4 engages a ramp 16 on the body 8 of the catheter 2. Theinteraction between the cam surface 14 and the ramp 16 causes thecutting element 4 to move to the cutting position and also causes a tip18 to deflect which tends to move the cutting element 4 toward thetissue to be cut.

The cutting element 4 is coupled to a shaft 20 that extends through alumen 21 in the catheter 2. Catheter 2 is coupled to exemplary cutterdriver 5. Cutter driver 5 is comprised of motor 11, power source 15 (forexample one or more batteries), microswitch (not shown), housing 17(upper half of housing is removed as shown), lever 13 and connectionassembly (not shown) for connecting shaft 20 to driver motor 11. Cutterdriver 5 can act as a handle for the user to manipulate catheter 2.Lever 13, when actuated to close a microswitch, electrically connectspower source 15 to motor 11 thereby causing rotation of cutting element4. The cutting element 4 is rotated about a longitudinal axis LA whenthe shaft 20 rotates. The cutting element 4 is rotated at about 1 to160,000 rpm but may be rotated at any other suitable speed dependingupon the particular application. Further description of catheterssimilar to catheter 2 is found in U.S. patent application Ser. No.10/027,418 (published as US 2002/0077642 A1) to Patel et al., entitled“Debulking Catheter”, the contents of which are incorporated byreference herein.

Referring to FIG. 5, the cutting element 4 is shown when viewed alongthe longitudinal axis LA. The term “along the longitudinal axis” as usedherein shall mean for example the view of FIG. 5 that shows the distalend of the cutting element 4 when viewed in the direction of thelongitudinal axis and/or the axis of rotation. The cutting element 4 hasa cutting edge 22 that may be a continuous, uninterrupted,circular-shaped edge although it may also include ridges, teeth,serrations or other features without departing from the scope of theinvention. The cutting edge 22 may be at a radially outer edge 23 of thecutting element 4 when the cutting element 4 is in the cutting position.

The cutting element 4 has a cup-shaped surface 24, which directs thetissue cut by the cutting edge 22 into the tissue chamber 12. Thecup-shaped surface 24 may be a smooth and continuous surface free ofthroughholes, teeth, fins or other features, which disrupt the smoothnature of the surface 24 for at least half the distance from thelongitudinal axis LA to the outer radius at the cutting edge 22. Thecup-shaped surface 24 may also be free of any such features throughoutan area of at least 300 degrees relative to the longitudinal axis LA.Optionally, one or more raised elements 26 extend outwardly from thecup-shaped surface 24 with FIG. 5 showing two raised elements 26. Theraised element 26 is a small wedge of material that rises relativelyabruptly from the cup-shaped surface 24. Optionally, some of or all ofthe cutter may be comprised of an abrasive surface. Further descriptionof additional embodiments usable as cutters in catheter 2 is found inU.S. Patent Application Ser. No. 61/173,845 to Moberg et al., entitled“Methods And Devices For Cutting/Abrading Tissue”, the contents of whichare incorporated by reference herein.

FIGS. 6, 6A, 7 and 8 illustrate one embodiment of an easily cleanedtissue chamber. Tissue collection chamber 12 is comprised of outersheath 61 having inward extending edges 61 a, one or more slots 61 b anddistal opening 64 and further comprised of shim sleeve 63 having lumen68 and window 63 w. Shim sleeve 63 is axially slidable relative to outersheath 61 and inward edges 61 a limit the distalmost excursion of shimsleeve 63. Cutter 4 is slidably received within lumen 68 of shim sleeve63 and can extend through window 63 w and window 6. The portion of shimsleeve 63 distal to window 63 w is circular in cross section to promoteuniform circumferential expansion of distal region 65 when shim sleeve63 is distally advanced, and is partially circular in cross sectionproximal to window 6 to allow catheter 2 to bend in the vicinity of ramp16 (see FIG. 9). Distal region 65 of outer sheath 61 has an expandablediameter due to presence of slots 61 b. Distal region 65 forms anexpandable tip. In various embodiments 2, 3, 4, 6, 8, 12, 16 or moreslots 61 b are contemplated. In some embodiments outer sheath 61 ispre-programmed to assume a normally closed position in which distalopening 64 is small or functionally closed such that deposits collectedin tissue chamber 12 cannot exit through distal opening 64. With shimsleeve 63 in a first position (FIG. 6) outer sheath distal region 65 hasa distally tapering diameter, optionally with distal opening 64. Withshim sleeve 63 in a second position (FIGS. 7 and 8) outer sheath distalregion 65 has an enlarged diameter, through which cutter 4 can beslidably received. In some embodiments cutter 4 can be extended out ofdistal opening 64 of outer sheath with shim sleeve 63 in the secondposition (FIG. 8) due to increased width of slots 61 b and enlargeddistal diameter of sheath 61. In some embodiments chamber 12 is furthercomprised of guidewire lumen 66 having proximal opening 66 p and distalopening 66 d.

Outer sheath 61 may be comprised of thermoplastic polymer, thermosetpolymer, thermoplastic elastomer, rubber, nylon, polyimide,polyurethane, or other materials and may further comprise a backbone ofresilient material such as for example nitinol or stainless steel.Processes such as extrusion or other processes may be used to fabricateouter sheath 61. Processes such as insert molding, polymer reflow,compression molding, or other processes may be used to fabricate distalend of outer sheath 61. Inward edges 61 a can be made by deforming theedges inward, heating the edges in the deformed position and removingthe heat to allow the edges to cool and retain the deformed state. Slots61 b can be made by cutting, stamping, laser cutting, may be molded in,or can be made by other processes. Shim sleeve 63 may be comprised ofrigid polymer or metal such as polyetheretherketone (PEEK), polyimide,polyester, liquid crystal polymer, nitinol, stainless steel, or othermaterials, and may be fabricated by processes such as extrusion.Guidewire lumen 66 may be comprised of a tube bonded to outside ofsheath 61. In another embodiment sheath 61 may be comprised of bilumentubing. Guidewire lumen 66 may be comprised of a lumen formed from thewall of outer sheath 61 using thermal processes at least in part.

Exemplary methods of using atherectomy catheter 2 comprised of tissuechamber 12 to cut and remove material from a body of a patient are nowdescribed. Using techniques known in the art, a guidewire GW ispercutaneously inserted into a patient's body and advanced to a regionof interest in a patient's blood vessel V. Using imaging techniques suchas fluoroscopy a diseased portion of the vessel is identified and anatherectomy catheter (such as catheter 2) comprised of tissue chamber 12having appropriate characteristics for treatment site T is chosen. Shimsleeve 63 is positioned such that window opening 63 w and window opening6 are aligned. Catheter 2 is advanced over the guidewire to thetreatment site with the cutting element in a stored position (FIG. 2).Using imaging techniques such as fluoroscopy the cutting element ispositioned at a desired location relative to (in some methods proximalto) the treatment site.

The main body of catheter 2 is held stationary and cutting element 4 isthen moved proximally so that the ramp 16 and cam surface 14 engage tomove the cutting element 4 to the cutting position of FIG. 3 (i.e.exposed through windows 6 and 63 w) and to deflect the tip of thecatheter 2 to move the cutting element 4 toward the tissue to be cut.Cutting element rotation about longitudinal axis LA is activated usinglever 13. Catheter 2 is advanced distally causing cutter blade 22 to cutmaterial M from luminal surface LS of vessel V. Cup shaped surface 24directs cut fragments F of material M through windows 6 and 63 w intolumen 68 of tissue collection chamber 12 (FIG. 9).

When the catheter operator decides to empty fragments F from tissuecollection chamber 12, cutter 4 is advanced distally to move cutter 4into the stored position and rotation of the cutting element is stopped(FIG. 10). Catheter 2 is retracted proximally and removed from the body.Shim sleeve 63 is next advanced distally to deflect distal portion ofsheath 61, causing opening 64 to enlarge and width of slots 61 b towiden. In some methods shim sleeve 63 is advanced to contact inwardedges 61 a of sheath 61. Cutter 4 may then be advanced to expelfragments F from lumen 68 of chamber 12 (FIG. 11) through distal opening64.

If further material removal from treatment site T is desired, cuttingelement 4 may be withdrawn to the storage position and shim sleeve 63can be withdrawn to the first position thereby causing distal region 65of sheath 61 to return to the closed position. Catheter 2 can then bere-inserted into vessel V and further material may be removed fromluminal surface LS as described above.

FIGS. 12 and 13 illustrate another embodiment of an easily cleanedtissue chamber. Tissue collection chamber 12′ is comprised of outersheath 121 having lumen 128 and push shaft 123 attached to tip 125. Pushshaft 123 is axially slidable relative to outer sheath 121, isapproximately semi-circular in cross section and is received withinlumen 128 of sheath 121. Tip 125 has reduced diameter proximal portion125 p which is slidably received within lumen 128 of sheath 121. Cutter4 is slidably received within lumen 128 of sheath 121 at the same timepush shaft 123 is also within lumen 128. Push shaft 123 is rotationallyaligned such that window 6 is not blocked by push shaft 123. Distalregion 125 d of tip 125 may be tapered to a smaller diameter thanproximal portion of tip 125 p. With push shaft 123 and tip 125 in afirst position (FIG. 12) tip proximal portion 125 p is slidably receivedwithin lumen 128 of sheath 121 and fragments of material removed fromthe luminal wall of the vessel cannot exit lumen 128 from distal end 121d of sheath 121. With push shaft 123 in a second position (FIG. 13) tip125 is displaced from distal end 121 d of sheath 121 by a distance D andfragments of material removed from the luminal surface of a vessel canexit lumen 128 through distal end 121 d of sheath 121. In someembodiments cutter 4 can be extended out of distal end 121 d of outersheath 121 to displace fragments from lumen 128. In some embodimentschamber 12′ is further comprised of guidewire lumen 126 having proximalportion 126 p and distal portion 126 d.

Outer sheath 121 may be comprised of thermoplastic polymer, thermosetpolymer, polyimide, polyetheretherketone (PEEK), nylon, or othermaterials. Processes such as extrusion or other processes may be used tofabricate outer sheath 121. Push shaft 123 may be comprised of rigidpolymer or metal such as PEEK, polyimide, polyester, liquid crystalpolymer, nitinol, stainless steel, or other materials, and may befabricated by processes such as extrusion. Tip 125 may be comprised ofthermoplastic elastomer, polyether block amide (PEBAX), silicone rubber,or other materials, and may be fabricated by processes such asextrusion, molding, insert molding, dipping, machining, or otherprocesses. Guidewire lumen 126 may be comprised of a tube bonded tooutside of sheath 121 and tip 125. In another embodiment sheath 121 maybe comprised of bilumen tubing, and in yet another embodiment tip 125may be comprised of a guidewire lumen therethrough. Guidewire lumen 126may also be comprised of a lumen formed from wall of outer sheath 121using thermal processes at least in part.

Exemplary methods of using atherectomy catheter 2 comprised of tissuechamber 12′ to cut and remove material from a body of a patient are nowdescribed. Using techniques known in the art, a guidewire GW ispercutaneously inserted into a patient's body and advanced to a regionof interest in a patient's blood vessel V. Using imaging techniques suchas fluoroscopy a diseased portion of the vessel is identified and anatherectomy catheter (such as catheter 2) comprised of tissue chamber12′ having appropriate characteristics for treatment site T is chosen.Push shaft 123 is withdrawn to the first position such that distal end121 d of sheath 121 is sealed shut by tip 125. Catheter 2 is advancedover the guidewire to the treatment site with the cutting element in astored position (FIG. 2). Using imaging techniques such as fluoroscopythe cutting element is positioned at a desired location relative to (insome methods proximal to) the treatment site.

The main body of catheter 2 is held stationary and cutting element 4 isthen moved proximally so that the ramp 16 and cam surface 14 engage tomove the cutting element 4 to the cutting position of FIG. 3 (i.e.exposed through window 6) and to deflect the tip of the catheter 2 tomove the cutting element 4 toward the tissue to be cut. Cutting elementrotation about longitudinal axis LA is activated using lever 13.Catheter 2 is advanced distally causing cutter blade 22 to cut materialM from luminal surface LS of vessel V. Cup shaped surface 24 directs cutfragments F of material M through window 6 into lumen 128 of collectionchamber 12′ using methods similar to that illustrated in FIG. 9.

When the catheter operator decides to empty fragments F from collectionchamber 12 cutter 4 is advanced distally to move cutter 4 into thestored position and rotation of the cutting element is stopped (FIG.14). Catheter 2 is retracted proximally and removed from the body. Pushshaft 123 is next advanced distally to separate tip 125 from distal end121 d of sheath 121 by distance D, allowing fragments F to exit fromdistal end of lumen 128. In some methods cutter 4 may be advanced toexpel fragments F from lumen 128 of chamber 12′ (FIG. 15).

If further material removal from treatment site T is desired, cuttingelement 4 may be withdrawn to the storage position and push shaft 123can be withdrawn to the first position thereby causing tip 125 to returnto the closed position. Catheter 2 can then be re-inserted into vessel Vand further material may be removed from luminal surface LS as describedabove.

In addition to use in blood vessels the invention is envisioned to beuseful for removal of blockages in other lumens such as natural orartificial grafts, stent-grafts, anastomotic sites, fistulae, or otherlumens.

The present invention has been described in connection with preferredembodiments but may, of course, be practiced while departing from theabove described embodiments.

The above description and the drawings are provided for the purpose ofdescribing embodiments of the invention and are not intended to limitthe scope of the invention in any way. It will be apparent to thoseskilled in the art that various modifications and variations can be madewithout departing from the spirit or scope of the invention. Thus, it isintended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents. Further, while choices formaterials and configurations may have been described above with respectto certain embodiments, one of ordinary skill in the art will understandthat the materials and configurations described are applicable acrossthe embodiments.

1. An atherectomy catheter comprising: a body having an opening; arotatable shaft coupled to the body, the rotatable shaft being rotatableabout a longitudinal axis of the shaft; a tissue collection chambercoupled to the body and positioned distal to the cutting element; and acutting element coupled to the rotatable shaft, the cutting elementhaving a cup-shaped surface and a cutting edge, the cup-shaped surfacebeing configured to re-direct tissue cut by the cutting edge in a distaldirection when the cup-shaped surface moves in the distal direction,wherein the tissue collection chamber has a first closed positioncapable of retaining cut tissue in the chamber and a second openposition capable of allowing expulsion of cut tissue from the chamber,wherein the tissue collection chamber comprises an expandable tip at adistal region of the catheter, the expandable tip having a first closedposition capable of retaining cut tissue in the chamber and a secondopen position capable of allowing expulsion of cut tissue from a distalopening at a distal end of the chamber, and wherein in the second openposition, the cutting element is configured to extend distally throughthe distal opening to expel the cut tissue.
 2. The catheter of claim 1,wherein the tissue collection chamber comprises a sheath having a lumen.3. The catheter of claim 2, wherein the tissue collection chambercomprises one or more slots in a distal region of the sheath.
 4. Thecatheter of claim 2, wherein the tissue collection chamber comprises twoor more slots in a distal region of the sheath.
 5. The catheter of claim2, wherein a distal region of the sheath has a distally taperingdiameter.
 6. The catheter of claim 3, wherein the tissue collectionchamber has the distal opening in the first closed position.
 7. Thecatheter of claim 2, wherein the tissue collection chamber comprises ashim sleeve disposed within the lumen of the sheath, the shim sleevebeing axially slidable relative to the sheath, and the shim sleevehaving a lumen.
 8. The catheter of claim 7, wherein the shim sleevecomprises a window.
 9. The catheter of claim 8, wherein the cuttingelement can be deployed through the shim sleeve window and the openingof the catheter.
 10. The catheter of claim 7, wherein a distal region ofthe sheath can be expanded by moving the shim sleeve distally.
 11. Thecatheter of claim 3, wherein the distal region of the sheath comprises2, 3, 4, 6, 8, 12, or 16 slots.
 12. The catheter of claim 2, wherein thesheath is pre-programmed to assume the first closed position.
 13. Thecatheter of claim 7, wherein the cutting element can be extendeddistally through the lumen of the shim sleeve.
 14. The catheter of claim13, wherein the cutting element can be extended distally through thedistal opening of the sheath when the tissue collection chamber is inthe second open position.
 15. The catheter of claim 1, wherein thetissue collection chamber comprises a guidewire lumen.
 16. The catheterof claim 2, wherein the tissue collection chamber comprises one or moreslots in a distal region of the sheath, the distal region of the sheathhas a distally tapering diameter, and the tissue collection chambercomprises a shim sleeve disposed within the sheath, the shim sleevebeing axially slidable relative to the sheath, and the shim sleevehaving a lumen.
 17. The catheter of claim 16, wherein the distal regionof the sheath can be expanded by moving the shim sleeve distally. 18.The catheter of claim 1, wherein the cutting edge is a radially outeredge of the cutting element.
 19. The catheter of claim 1, wherein thecutting element is movable between a stored position and a cuttingposition relative to the opening.
 20. The catheter of claim 19, whereinthe cutting element is moved between the stored position and the cuttingposition by sliding the cutting element against a cam surface.
 21. Thecatheter of claim 20, wherein a distal portion of the catheter relativeto a proximal portion is deflected by sliding the cutting elementagainst the cam surface.
 22. A method of removing tissue from a bodylumen, the method comprising: providing an atherectomy catheter, theatherectomy catheter comprising: a body having an opening; a rotatableshaft coupled to the body, the rotatable shaft being rotatable about alongitudinal axis of the shaft; a tissue collection chamber coupled tothe body and positioned distal to the cutting element; and a cuttingelement coupled to the rotatable shaft, the cutting element having acup-shaped surface and a cutting edge, the cup-shaped surface beingconfigured to re-direct tissue cut by the cutting edge in a distaldirection when the cup-shaped surface moves in the distal direction,wherein the tissue collection chamber has a first closed positioncapable of retaining cut tissue in the chamber and a second openposition capable of allowing expulsion of cut tissue from the chamber,and wherein the tissue collection chamber comprises an expandable tip ata distal region of the catheter, the expandable tip having a firstclosed position capable of retaining cut tissue in the chamber and asecond open position capable of allowing expulsion of cut tissue from adistal opening at a distal end of the chamber; placing the catheter inthe body lumen; moving the catheter in the body lumen to contact thecutting element with the tissue in the body lumen; cutting the tissue;collecting the cut tissue in the tissue collection chamber; expandingthe expandable tip; and advancing the cutting element distally to expelthe cut tissue through the distal opening.
 23. The method of claim 22,wherein the catheter is moved in a distal direction to contact thecutting edge with the tissue in the body lumen.
 24. The method of claim22, wherein the catheter is placed in the body lumen with the cuttingelement in a stored position and the catheter is moved to contact thematerial with the cutting element in a cutting position.
 25. The methodof claim 22, further comprising removing the catheter from the bodylumen, and removing the cut tissue from the tissue collection chamberafter the catheter has been removed from the body lumen.
 26. The methodof claim 25, wherein the catheter is removed from the body lumen withthe tissue collection chamber in the first closed position and the cuttissue is removed from the tissue collection chamber with the tissuecollection chamber in a second open position capable of allowingexpulsion of cut tissue from the tissue collection chamber.